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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02705612
Other study ID # XJFL-2016-02-LACC-Nimotuzumab
Secondary ID
Status Recruiting
Phase Phase 2
First received March 5, 2016
Last updated March 9, 2016
Start date September 2015
Est. completion date September 2018

Study information

Verified date March 2016
Source Fourth Military Medical University
Contact Mei Shi, MD
Phone 0086-029-84775432
Email mshi82@fmmu.edu.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.


Description:

For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc.

In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 2018
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 18 Years to 70 Years,female

- Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis.

- no chance of surgery confirmed by more than two deputy chief doctors of gynecology.

- Moderate or high expression of EGFR

- The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment.

- WBC=3.5×10E9/L,ANC=1.5×10E9/L;HB=90g/L,PLT=100×10E9/L

- ALT, AST and Cr below 1.5 times of normal level

- Willing to accept treatment

- Ability to comply with trial requirements KPS=70

Exclusion Criteria:

- Evidence of distance metastasis

- Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm)

- Couldn't examine with pelvic MRI due to a variety of reasons

- Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy

- Diagnosed with another malignant tumor in 5 years

- Used to be a volunteer of other clinical trial.

- Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs

- Severe medical history of lung ,liver, kidney or heart.

- Active infection in any part of the whole body.

- Examination results showed radiotherapy contraindications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Cisplatin

Radiation:
External Beam Radiation Therapy

Internal Radiation Therapy

Drug:
nimotuzumab


Locations

Country Name City State
China Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival rate Described with Kaplan-Meier curves and unadjusted logrank tests. at 3 years No
Primary disease free survival rate at 3 years No
Primary non-distant metastasis survival rate at 3 years No
Primary survival period of non-progressive. at 3 years No
Secondary Quality of life 3 years No
Secondary Radiation protocol compliance 3 years No
Secondary Rate of acute and long-term toxicities 3 years Yes
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